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[e-drug] New report on the Safety of Medicines in Sub-Saharan Africa

E-DRUG: New report on the Safety of Medicines in Sub-Saharan Africa

With an increase in access to new essential medicines in Africa, there is a 
greater need to monitor and promote safety, quality, and effectiveness of 
medicines. The burden of adverse events from poor product quality, adverse drug 
reactions, and medication errors pose great challenges to health care systems, 
besides the impact on morbidity and mortality. Yet few developing countries 
have the structures, systems, or resources in place to conduct 
pharmacovigilance activities, and countries often lack unbiased, evidence-based 
information to help guide regulatory and patient safety decisions. 

"Safety of Medicines in sub-Saharan Africa: Assessment of Pharmacovigilance 
Systems and their Performance" which has been developed by the USAID funded and 
Management Sciences for Health (MSH) implemented Strengthening Pharmaceutical 
Systems (SPS) Program, addresses this gap and provides a comprehensive 
description and analysis of pharmacovigilance systems and their performance in 
sub-Saharan Africa. The data was compiled in 2011 using more than 400 
literature reviews and assessments in 46 sub-Saharan African countries. 

This thorough work presents critical findings-achievements made to date and 
challenges countries are faced with-and recommendations to enhance medicine 
safety systems in developing countries. All stakeholders including regulators, 
public health program managers, pharmaceutical industry, donors, health care 
workers, and patients can take key messages from this report on their roles and 
responsibilities that will lead to actions to improve patient safety and health 

This study was made possible through an interagency agreement between the US 
Food and Drug Administration (FDA) and the US Agency for International 
Development (USAID). The combined support enabled the SPS Program to implement 
the study. The opinion expressed in this report does not necessarily reflect 
the official position of the FDA, the USAID or the US Government. The contents 
are the responsibility of MSH.

Link to the report: 

Recent comments about the report:

"Regulatory authorities have responsibility beyond getting the product to the 
market. The lip service that is currently paid to post-marketing surveillance 
is well documented by this report...."
Margareth Ndomondo-Sigonda, African Medicines Regulator

"Patient safety should be at the center of all we do. This study has 
highlighted how far we are from that goal.... But it is not without hope. In 
its recommended strategies, the report shows opportunities exist for everyone 
to act. What is needed is the will to act now!"
Eva Ombaka, Visiting Lecturer, St. John's University, Tanzania, and formerly 
with the Ecumenical Pharmaceutical Network

"The result of the study clearly showed little efforts by public health 
programs. Monitoring and ensuring the safe use of medicines are critical to the 
success of these programs. Global partners must, as a matter of urgency, 
integrate in their planning phase, functional medicine safety systems to 
monitor the effects of donated products."
Paul Orhii, Director General, National Agency for Food and Drug Administration 
and Control, Nigeria

"Pharmacovigilance is a critical component of health systems and of importance 
to all stakeholders, regulators, industry, health workers, and patients-for 
whom it may well be a matter of life and death."
Alex Dodoo, Director, WHO Collaborating Centre for Advocacy and Training in 
Pharmacovigilance, Accra, Ghana 

For questions, please contact pharmacovigilance@msh.org.   

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